The invention relates to systems and methods for dynamic automation, such as automation related to endotoxin assays.
Robotic systems and components have been implemented widely in various industries. For example, robotic systems and components are well known in manufacturing of durable and consumer goods such as automotive, electronics, pharmaceuticals and biotech, and other consumer goods. Additionally, robotic systems and components are often employed in biotech, medical, and laboratory settings such as to perform assays. These robotic systems and components—whether in a laboratory or manufacturing setting—are typically controlled using static automation scripts as will be detailed herein.
Assays are investigative procedures in laboratory, medicine, pharmacology, environmental biology, or molecular biology for qualitative assessment or quantitative measurement of the presence, amount, or functional activity of a target entity (e.g., the “analyte”). The analyte may be a drug, a biochemical substance, or a cell in an organism or organic sample and the measured entity may be the analyte. Assays usually aim to measure an intensive property of the analyte and express it in relevant measurement units, such as molarity, density, functional activity in enzyme international units, degree of some effect in comparison to a standard, etc.
Endotoxins are a type of pyrogen and are natural compounds found in the outer cell membrane of Gram-negative bacteria and may impact numerous biological activities. The Limulus Amebocyte Lysate (LAL) test was commercially introduced in the 1970s. LAL is derived from the blood cells, or amebocytes, of horseshoe crabs. It was observed that blood cells from horseshoe crabs were found to clot in the presence of endotoxin, and this technology was used in the development of endotoxin detection assays. Today, endotoxin tests are performed on raw and in-process materials, and for the final release of products in the pharmaceutical and medical device industries.
Assay methods, including endotoxin assays, may be performed or facilitated, in part, using computer system(s) configured to control laboratory robots. These robots may be configured to move biological or chemical samples and laboratory equipment with relative precision and efficiency. The laboratory robots, however, may be pre-programmed with predetermined robot automation scripts by laboratory technicians for each assay or test the robots perform, and thus, they are static and inflexible. For example, static robotic control involves predetermining where the components will be positioned, then developing the robotic control code required for the item to be created. The same components must be positioned at the same locations each time the control code is executed, which means that processing (and the item that is created) is always the same, and to create a different item, new robotic control code must be developed. In this way, the robotic scripts are static (e.g., once a script is created, it runs the same way each and every time without any flexibility), creating a dedicated script for each assay or test can be tedious and time consuming, and script creation requires specialized scripting knowledge. Moreover some scripts may require some “babysitting” with human intervention to apply, for example, manual actions at various points in the assay or testing process.